Silicone-hydrocoated ureteral stents encrustation and biofilm formation after 3-week dwell time: results of a prospective randomized multicenter clinical study.

OBJECTIVE: To explore the risk of encrustation and biofilm formation for silicone ureteral stents compared to percuflex polymer stents, through a randomized multicenter study. PATIENTS AND METHODS: Design, setting and participants: A Multicenter, prospective, randomized, single blind, comparative study of hydrocoated silicone stent (Coloplast Imajin® hydro) versus Percuflex™ Plus stent (Boston Scientific), in 141 patients treated by flexible URS for a kidney stone. The study had ethical committee approval in the respective hospitals. Outcome measurements and statistical analysis: Endpoints related to encrustation were biofilm formation and mineral encrustation after a period of 3-week indwelling time. They were evaluated at removal through a scoring scale of ureteral stents encrustation, infrared spectroscopy and optical microscopy of inner and outer surfaces of tips, angles and along the stent's body. Comparison was performed using ANOVA. RESULTS: 119 stents were available after removal for analysis, 56 in the silicone and 63 in the Percuflex TM Plus group. Mean dwelling duration was 21.8 days for silicone, 22.1 days for PercuflexTM Plus. There was significantly more biofilm on Percuflex™ Plus compared to silicone (1.24 ± 0.08 vs 0.93 ± 0.09, p = 0.0021), and more mineral encrustation (1.22 ± 0.10 vs 0.78 ± 0.11, p = 0.0048), respectively. CONCLUSIONS: This multicenter randomized study shows that silicone-hydrocoated stents are less prone to encrustation than PercuflexTM Plus after a 3-week dwelling period and confirms the low encrustation potential of silicone.